# Boston Scientific Corp: PMA supplement approved for Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Syste

**Score:** 30/100

| Field | Value |
|---|---|
| Sponsor | Boston Scientific Corp |
| Product | Precision Spectra SCS Systems; Precision Novi SCS Systems; Precision Montage MRI SCS Systems; Spectra Wave Writer SCS Sy |
| Generic / ingredient | Stimulator, spinal-cord, totally implanted for pain relief |
| Approval | PMA supplement (device change) |
| Application | P030017 S399 |
| Decided | 2026-09-22 |
| Panel / class | Neurology |
| Sponsor location | Valencia, CA |

## Why this score


Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P030017S399). Last refreshed: 2026-11-04T06:06:18.796Z.
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.